Regulatory Affairs
Lifecycle monitoring of:
- Medicinal Products for Human and Veterinary Use
- Medical Devices
- Cosmetics
- Food Supplements
- Biocidal Products
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Quality Assurance
- Implementation and Maintenance of Quality Management Systems, based on ISO 9001, ISO 13485, GMP’s, GDP’s references
- Preparation and Revision of SOP’s
- Support on certification by the Competent Authorities
- Internal Audits of Quality Management Systems
Entity Licensing
- Manufacturers of Medicinal Products for Human Use
- Manufacturers of Medical Devices
- Wholesale Distributors of Medicinal Products for Human Use
- Wholesale Distributors of Medicinal Products for Veterinary Use
- Wholesale Distributors of Medical Devices
- Retail Establishments of Medicinal Products for Veterinary Use
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Marketing and Advertising
- Regulatory support
- Elaboration, review and notification of advertising materials
- Product Marketing
- Market research
- Brands representation
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Product Design and Development
- Secondary Packaging of Pharmaceutical Products
- New products
- Redesign
